P-Hist News

WEDNESDAY, March 22, 2017 – The U.S. Food and Drug Administration has approved a new drug for Parkinson's disease. Xadago (safinamide) pills were given the green light as an add-on treatment for people taking levodopa/carbidopa and experiencing "off" episodes. These are periods when medication effectiveness wanes, leading to a rise in symptoms such as tremor and difficulty walking. "Parkinson's is a relentless disease without a cure," Dr. Eric Bastings said in an FDA news release. "We are committed to helping make additional treatments for Parkinson's disease available to patients," added Bastings, deputy director of neurology products in the FDA's Center for Drug Evaluation and Research. The FDA's approval of the drug is based on two clinical trials. The studies included a total of nearly 1,200 patients who were taking levodopa and experiencing "off" time. Those who added Xadago to ... Read more

TUESDAY, Jan. 5, 2016 – Instead of turning to over-the-counter cough and cold remedies, parents should consider treating their children with home remedies, says a leading group of U.S. pediatricians. Like all medications, even cold and could remedies available without a prescription can cause serious side effects in young children, the American Academy of Pediatrics cautions. Because of the risks, the U.S. Food and Drug Administration in 2008 recommended that children younger than 4 years old never be treated with over-the-counter cough and cold medicines. Children between 4 and 6 years old should only take these remedies under the direction of their doctor, the academy said in a news release. But children older than 6 can safely take over-the-counter drugs if the dosage instructions on the package are followed correctly. There are safer, more convenient and less costly ways to provide ... Read more

TUESDAY, May 5, 2015 – It can be difficult for parents to tell whether their child has a cold or hay fever, but there are ways to distinguish between the two, experts say. "Runny, stuffy or itchy noses, sneezing, coughing, fatigue, and headaches can all be symptoms of both allergies and colds, but when parents pay close attention to minor details they will be able to tell the difference," Dr. Michelle Lierl, a pediatric allergist at Cincinnati Children's Hospital Medical Center, said in a hospital news release. "Children who have springtime or fall allergies have much more itching of their noses; they often have fits of sneezing and usually rub their noses in an upward motion," Lierl explained. "They also complain about an itchy, scratchy throat or itchy eyes, whereas with a cold, they don't." Nasal discharge is usually clear if someone has allergies and yellowish if someone has a ... Read more

FRIDAY, March 27, 2015 – Medications for children – even those you can buy over-the-counter – can be dangerous if a child is given too much, one expert says. That's why pharmacist Sheila Goertemoeller, of the Cincinnati Drug and Poison Information Center, wants parents and other caregivers to know how to safely administer these drugs. Before giving medication to children, parents should carefully read the instructions first and use the appropriate measuring device to prevent accidental overdoses, cautioned Goertemoeller. These precautions are especially important if you're giving medicine to a sick child in the middle of the night, Goertemoeller noted. Dosing errors are made by 41 percent of parents, according to research from the American Academy of Pediatrics. Just taking a few minutes to turn on a light and read the directions will help ensure children get the right amount, ... Read more

MONDAY, Oct. 20, 2014 – A child receives the wrong medication or the wrong dosage every eight minutes in the United States, according to a recent study. Nearly 700,000 children under 6 years old experienced an out-of-hospital medication error between 2002 and 2012. Out of those episodes, one out of four children was under a year old. As the age of children decreased, the likelihood of an error increased, the study found. Though 94 percent of the mistakes didn't require medical treatment, the errors led to 25 deaths and about 1,900 critical care admissions, according to the study. "Even the most conscientious parents make errors," said lead author Dr. Huiyun Xiang, director of the Center for Pediatric Trauma Research at Nationwide Children's Hospital in Columbus, Ohio. That conscientiousness may even lead to one of the most common errors: Just over a quarter of these mistakes involved a ... Read more

WEDNESDAY, March 19, 2014 – Over-the-counter sinus and pain remedies that combine two common ingredients – phenylephrine and acetaminophen – might cause serious side effects such as high blood pressure, dizziness and tremors, New Zealand researchers warn. These side effects occur because acetaminophen (the main ingredient in Tylenol) boosts the effects of phenylephrine, according to a report in the March 20 issue of the New England Journal of Medicine. Products containing this drug combination include Tylenol Sinus, Sudafed PE Sinus, Benadryl Allergy Plus Sinus and Excedrin Sinus Headache. "What we found was surprising because it hasn't been studied or reported," said lead researcher Hartley Atkinson, managing director of AFT Pharmaceuticals, Ltd., in Auckland. Phenylephrine, which replaced pseudoephedrine in many over-the-counter medications, relieves nasal congestion from colds, ... Read more

MONDAY, Nov. 11 – Restrictions placed on cough and cold medicines may be working, with fewer young children ending up in the ER because of bad side effects tied to the drugs, new research shows. The drop in kids' illnesses came about after drug manufacturers voluntarily withdrew cough and cold medications for this age group from the market in 2007, and after drug labeling changes put in place in 2008. The labeling changes advised that the products were not for use in children under 4. "The change [in ER admissions] was associated with those two events," said study author Dr. Lee Hamilton, a medical officer in the division of healthcare quality promotion at the U.S. Centers for Disease Control and Prevention. "We saw that in children under 2 years old, adverse events from cough and cold medicines dropped from one in 25 of all emergency department visits for adverse drug events to about ... Read more

TUESDAY, April 23 – More than 40 percent of American parents give over-the-counter cough and cold medicines to kids under age 4 even though they're too young for such products, a new survey finds. In young children, these medicines can cause allergic reactions, increased or uneven heart rate, slow and shallow breathing, confusion or hallucinations, drowsiness or sleeplessness, convulsions, nausea and constipation. Since 2008, labels on cough and cold medicines have warned that they should not be given to children under age 4. The use of cough and cold medicines in children in that age group did not differ by parent gender, race/ethnicity or household income, according to the University of Michigan C.S. Mott Children's Hospital National Poll on Children's Health. The survey included 498 parents of children aged 3 and under. Children can get five to 10 colds a year, so parents often turn ... Read more

SUNDAY, March 17 – It's the time of year when cold season and allergy season overlap, and parents need to know the active ingredients in the medicines they give their children for these conditions, the U.S. Food and Drug Administration warns. Taking more than one medicine at a time could cause serious health problems if the drugs have the same active ingredient, which is the component that makes the medicine effective against a particular condition. For over-the-counter products, active ingredients are listed first on a medicine's Drug Facts label. For prescription medicines, active ingredients are listed in a patient package insert or consumer information sheet provided by the pharmacist, the FDA said. Many medicines have just one active ingredient. But combination medicines – such as those for allergy, cough or fever and congestion – may have more than one. Antihistamine is an ... Read more

WEDNESDAY, Oct. 31 – Boys may be more likely than girls to abuse over-the-counter drugs, new study results suggest. University of Cincinnati researchers looked at over-the-counter (OTC) drug abuse among students in grades 7 through 12 in 133 schools across greater Cincinnati who took part in a 2009-2010 survey. Early analysis of the data showed that 10 percent of students said they abused over-the-counter drugs such as cough syrups and decongestants. This type of drug abuse can result in accidental poisoning, seizures and physical and mental addictions, the study authors pointed out in a university news release. High rates of over-the-counter drug abuse were found among male and female junior high school students. However, boys had a higher risk of longtime use of over-the-counter drugs compared with girls, the investigators found. Teens who reported abusing over-the-counter drugs were ... Read more

WEDNESDAY, Dec. 21 – It's prudent to limit the use of over-the-counter cold and flu medications during pregnancy, experts say. This is because some medications may contain substances that are potentially harmful to developing fetuses, or that have not been well-studied for use in pregnant women. "Every year around this time, we get a significant number of calls from pregnant and breast-feeding women in California who are battling colds and are worried about which meds they can and can't take," said Christina Chambers, professor of pediatrics at University of California, San Diego and program director at the California Teratogen Information Service. To help expectant mothers who are sick this holiday season, Chambers offered these cold medicine safety tips: Take as little as possible. Over-the-counter cold remedies could contain up to six ingredients for a wide array of symptoms, such ... Read more

-- Over-the-counter medications may seem safer because they don't require a prescription. But they can still interact badly when alcohol enters the mix. The American Academy of Family Physicians mentions these popular medications that may have adverse effects if mixed with alcohol: NSAID pain relievers, which may lead to gastrointestinal bleeding if taken while consuming as few as two alcoholic drink per week. Acetaminophen, which may cause liver damage when taken with alcohol. Some OTC antihistamines can make you drowsy when taken with alcohol. Decongestants and cough medications that contain the cough suppressant dextromethorphan can increase drowsiness when taken with alcohol. Herbal supplements, such as kava kava, St. John's wort or valerian root, may increase drowsiness if taken with alcohol. Read more

WEDNESDAY, March 2 – The U.S. Food and Drug Administration said Wednesday that it plans to remove about 500 unapproved prescription cough, cold, and allergy medicines from pharmacy shelves. These drugs have not been evaluated by the FDA for safety and effectiveness, and they may be riskier to take than approved over-the-counter (OTC) drugs that treat these same conditions, agency officials explained. "This action is necessary to protect consumers from the potential risks posed by unapproved drugs, because we don't know what's in them, whether they work properly or how they are made," Deborah M. Autor, director of the agency's Office of Compliance at the Center for Drug Evaluation and Research, said during a morning news conference. Of particular concern are drugs that have time-release formulations, Autor said. "We know from experience that these type of products are complicated to ... Read more

WEDNESDAY, Feb. 16 – Many American parents of children aged 2 and younger still give over-the-counter cough and cold medicines to their kids despite U.S. Food and Drug Administration warnings to the contrary, researchers have found. In response to research linking over-the-counter (or OTC) cough and cold medicines to poisoning or death in hundreds of children ages 2 years and younger, the FDA said in 2008 that the products should not be given to children in this age group. In addition, studies have shown that these medicines have little benefit in controlling symptoms. A new national poll of over 300 parents of children ages 6 months to 2 years found that 61 percent of parents gave OTC cough and cold medicines to their children within the last 12 months. In addition, more than half of the parents said their child's doctor said the medicines are safe for children under 2 years, and ... Read more

TUESDAY, April 27 – Children who are overweight or obese appear to metabolize over-the-counter drugs differently than normal-weight children, a new study finds. This could result in complications at both ends of the spectrum, whether kids' bodies end up with more drug than they need or less. "There could be severe implications," said L'Aurelle Johnson, senior author of the research, which was to be presented Tuesday in Anaheim, Calif., at a meeting of the American Society for Pharmacology and Experimental Therapeutics, part of the Experimental Biology 2010 conference. "There could be adverse effects if the therapeutic agent is metabolized into an active form," she explained. "They could have higher systemic circulation of this particular agent, and they might have adverse events due to [overly] high concentrations in the system." On the contrary, if the therapeutic agent is metabolized ... Read more